Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

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This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)

Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF) [ Time Frame: baseline and up to 8 weeks or LOCF ]

Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.

Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.

Secondary Outcome Measures
:

Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF) [ Time Frame: up to 8 weeks or LOCF ]

Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8 [ Time Frame: Baseline and 8 weeks ]

Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.

Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8 [ Time Frame: Baseline and 8 weeks ]

Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.

Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata)) [ Time Frame: week 4 and week 8 ]

Number of participants with no recorded titration of Vardenafil after visit 3.

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Ages Eligible for Study:

18 Years to 64 Years (Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Stable heterosexual relationship

History of erectile dysfunction for at least 6 months

IIEF- EF Domain entry score (at Visit 2): >21 points

Documented metabolic syndrome according to the IDF (International Diabetes Foundation)

Subjects motivated for erectile dysfunction treatment

Documented, dated, written informed consent

Exclusion Criteria:

Any underlying cardiovascular condition

History of myocardial infarction

Uncontrolled atrial fibrillation

Resting hypotension

Postural hypotension within 6 months of Visit 1

History of congenital QT prolongation

Bleeding disorder

History of prostatectomy because of prostate cancer

Hereditary degenerative retinal disorders

History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy)